FDA.reportPublic FDA data

propranolol hydrochloride

Product NDC
50090-1501
11-digit product format
500901501
Labeler code
50090
Product ID
50090-1501_b566cbe1-2d29-4d46-bd9c-316e363c9174
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
propranolol hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA078703
Marketing category
ANDA
Marketing start
2013-03-11
Substance
PROPRANOLOL HYDROCHLORIDE
Active strength
80 mg/1
Pharmacologic classes
Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
propranolol hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PROPRANOLOL HYDROCHLORIDE80 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF8A3652H1V
Rxcui856569

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ba1babb5-1c2a-d9a8-0fd7-8f90d4f768cfProduct name220200609
a5696e6c-a559-4d6b-bb53-f324106f317cProduct name120140718
0f446d3d-c9e6-1844-b8e8-a836dc35e0deProduct name120140508
33a4b7b4-a3c1-3f95-a202-01166dd77c44Product name120140508
60519d27-227d-404a-38bc-37524c8b386bProduct name120140508
d5f30598-8f94-b083-f161-65d67f2ae12aProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-1501-02023-02-07C16284748780-1f386c649-f900-0266-e053-dadaa90a7c1aPropranolol Hydrochloride Extended-Release Capsules, USP
50090-1501-02023-01-30C16284748780-1f386c649-f900-0266-e053-dadaa90a7c1aPropranolol Hydrochloride Extended-Release Capsules, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-1501-0propranolol hydrochloride30 in 1 BOTTLECAPSULE, EXTENDED RELEASE3015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1501-0EA - Each50090-1501ff2d4885-04d8-4abd-afc8-2dbd51d690b612018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1501PROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]15Current NDC, Legacy NDC, 1 package rows20230810_d1cfdb57-0b04-43f7-bd10-c585f77385b3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856569propranolol HCl 80 MG 24HR Extended Release Oral CapsulePSNd1cfdb57-0b04-43f7-bd10-c585f77385b315
85656924 HR propranolol hydrochloride 80 MG Extended Release Oral CapsuleSCDd1cfdb57-0b04-43f7-bd10-c585f77385b315
856569propranolol hydrochloride 80 MG 24 HR Extended Release Oral CapsuleSYd1cfdb57-0b04-43f7-bd10-c585f77385b315

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-1501-05009015010030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (50090-1501-0) 2014-12-080000-00-00NoNoCurrent